CE Mark approval in September 2011 and to date over 100 commercial implants have been performed. The device is composed of a porcine biologic valve attached to a self-expanding nitinol stent designed for simple 2-step implantation and characterized by controlled positioning, self-seating in the native annulus resulting in a negligible paravalvular leak rate. The device was tested in patients at high-risk for mortality with open surgical repair. Methods: Ninety (90) patients (femaleϭ69%) with severe aortic stenosis, a mean age of 83.4 Ϯ 4.1 years, all presenting with NYHA Functional Class III or IV and a mean STS Score of 7.9 Ϯ 4.6 were enrolled in two studies in Germany at 6 centers. Patients are clinically followed at 7 and 30 days, at 6 and 12 months, and annually thereafter out to 5 years post-implant. The device was successfully implanted in 94.4% of patients (nϭ85) with a pacemaker implantation rate of 11.1% (nϭ10). Results: At 12 months the survival rate is 81.1% (nϭ73), the stroke rate is 4.4% (nϭ4), with no further re-intervention required on the implanted device since procedure. Of the returning patients, 87% presented with NYHA Functional Class I/II. The mean gradient at 6 months is 10.3 Ϯ 5.2 mmHg, the mean EOA is 1.5 Ϯ 0.4 cm2 and 77.3% of returning patients suffered no paravalvular leak, 21.2% exhibit mild paravalvular leak (ϩ1) and only 1 patient possesses a moderate paravalvular leak (ϩ2). Conclusions: These data confirm the safety profile at one year of this 2nd Generation TAVI system. We will report the full 12 months results of this multi-center, nonrandomized study of this transapically-placed transcatheter aortic valve at TCT 2012.

Background: Cardiovascular manifestation in patients with thrombotic thrombocytopenic purpura. Hypothesis: The aim of this study was to investigate the incidence of acute myocardial infarction (AMI), arrhythmias, congestive heart failure, and mortality in patients hospitalized for thrombotic thrombocytopenic purpura (TTP). Methods: Thirty-eight patients (27 women and 11 men), mean age 44 years, were hospitalized with the diagnosis of TTP confirmed by a hematologist. We investigated the incidence of AMI which developed during hospitalization for TTP. AMI was diagnosed by new electrocardiographic changes, increased serum cardiac troponin I levels, and clinical symptomatology. The patients with AMI were also monitored for development of arrhythmias during hospitalization. Results: Of the 38 patients, 8 (21%) developed new Q-wave AMI. There was no significant difference in baseline characteristics between patients who developed AMI and those who did not develop AMI. Of the 8 patients with AMI, 2 (25%) developed atrial fibrillation, 1 (13%) developed atrial flutter, 1 (13%) developed supraventriculartachycardia, and 2 (25%) developed congestive heart failure. Death occurred in 3 of 8 patients (38%) with AMI and in 1 of 30 patients (3%) without AMI (P < 0.01). Conclusions: New Q-wave AMI developed in 21% of 38 patients hospitalized with TTP. Supraventricular tachyarrhythmias developed in 50% of 8 patients with TTP who developed AMI. Patients hospitalized for TTP should be monitored for adverse cardiac events due to the high incidence of new AMI, supraventricular tachyarrhythmias, and mortality.

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IntroductionAlthough atherosclerotic disease cannot be cured, risk of recurrent events can be reduced by application of evidence-based treatment protocols involving aspirin, beta blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and statin medications. We studied atherosclerotic event rates in a patient population treated before and after the development of aggressive risk factor reduction treatment protocols.Material and methodsWe performed a retrospective chart review of patients presenting for follow-up treatment of coronary artery disease in a community cardiology practice, comparing atherosclerotic event rates and medication usage in a 2-year treatment period prior to 2002 and a 2-year period in 2005-2008. Care was provided in both the early and later eras by 7 board-certified cardiologists in a suburban cardiology practice. Medication usage was compared in both treatment eras. The primary outcome was a composite event rate of myocardial infarction, cerebrovascular events, and coronary interventions.ResultsThree hundred and fifty-seven patients were studied, with a follow-up duration of 12.1 (±3.5) years. There were 132 composite events in 104 patients (29.1%) in the early era compared to 40 events in 33 patients (9.2%) in the later era (p < 0.0001). From the early to the later eras, there was an increase in use of β-blockers (66% to 83%, p < 0.0001), angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (34% to 80%, p < 0.0001), and statins (40% to 90%, p < 0.0001).ConclusionsApplication of aggressive evidence-based medication protocols for treatment of atherosclerosis is associated with a significant decrease in atherosclerotic events or need for coronary intervention.